The stent for biliary and pancreatic duct was made available by QualiMed Innovative Medizinprodukte, a Q3 Medical Devices subsidiary.
The stent is made of polymers similar to those used in medical sutures. It remains in the biliary duct until the cholangitis is resolved, before it is slowly hydrolysed by the body. According to Dr Hairol Othman, a consultant hepatobiliary and pancreas surgeon at UKMMC, a patient has to undergo another procedure to remove the stents, when using the conventional ones.
The Archimedes device comes with three degradation times to accommodate the various disease states that require different indwelling times for treatment – fast absorbing (weeks), medium absorbing (months), and a long last (closer to a half year. Unlike traditional plastic biliary stents that are used hundreds of thousands of times per year and have to be removed and/or exchanged routinely, the Archimedes device can be used and implanted using the exact techniques applied with the existing technology with the added benefit of allowing the bile to flow on the outside of the devices as well as through the centre helping to minimise the potential for post-implant obstruction while eliminating the cost and risk associated with the removal procedures. The elimination of removal procedures is expected to significantly reduce total procedure cost for the patients that are treated with the Archimedes device. The device is for investigational purposes only and is not currently CE or FDA.
Speaking after the successful surgery, Dr Hairol said: "Archimedes biodegradable stents are a revolutionary new concept in the biliary and pancreatic duct drainage. They are easy to deploy and very convenient for the patients. They negate the need for a repeat ERCP, hence reducing patients' anxiety and inconvenience. Plus, they do incur only one cost compared with conventional stents."
Eric K Mangiardi, ceo of Q3 Medical, commented: "This is a significant milestone for the company as we continue to explore developments in the area of biodegradable implants, that will improve efficacy and eliminate cost for the patients and care givers that treat them. We are continuing our development in the areas of fully covered biodegradable esophageal and balloon expandable biodegradable, covered and uncovered biodegradable biliary and peripheral vascular devices that will further the advancement and treatment options for patients and doctors globally."
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History lesson: The Endoscopy Centre of UKM Medical Centre (UKMMC), Kuala Lumpur, has successfully used a biodegradable stent on a 56 year old patient